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CompletedNCT01262508Updated Feb 19, 2016

Development of Algorithms to Predict Hemodynamic Instability

An observational study in Sudden Cardiac Death, sponsored by Klinik für Kardiologie, Pneumologie und Angiologie. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-19.

Sponsored by Klinik für Kardiologie, Pneumologie und Angiologie · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.

Read the detailed description

70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing.

Autonomic reflex testing:

  • Heart Rate Characteristics
  • Heart Rate Variability
  • Heart Rate Turbulence
  • Blood Pressure Variability
  • Baroreflex Sensitivity
  • Hyperoxic Chemoreflex Sensitivity

Hemodynamic Monitoring:

  • Heart Rate Trends
  • Blood Pressure Trends
  • Pulse Wave Characteristics
  • Cardiac Output
  • Peripheral Vascular Resistance
  • Context information
02

Conditions studied

  • Sudden Cardiac Death

Keywords

  • autonomic nervous system
03

In context

Death, Sudden, Cardiac

314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.

This study's enrollment of 60 is below the median of 500 across 172 observational studies indexed under Death, Sudden, Cardiac.

Browse Death, Sudden, Cardiac studies →

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients being at risk of sudden cardiac death

Inclusion criteria

  • hospitalization
  • Age > 17 years

Exclusion criteria

Exclusion Criteria:

  • documented diseases of the central nervous system
  • impairment of mental health
  • age > 85 years
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)

Groups and cohorts

  • Risk Population

    Patients being suspected to be at risk of hemodynamic instability due to medical history

06

What researchers measure

Primary outcomes

  1. Autonomic Dysfunction

    Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing

    Time frame: 24 hours

Secondary outcomes

  1. Hemodynamic Deterioration

    Acute hemodynamic changes (Blood pressure changes \> 10 mm Hg, heart rate changes \> 5 bpm both within 30 seconds) of a patient as assessed by hemodynamic monitoring

    Time frame: 24 hours

07

Study locations

1 site
  • Heinrich-Heine-University
    Duesseldorf, NRW 40225, Germany
08

References and documents

Publications

  • Jungen C, Zeus T, Balzer J, Eickholt C, Petersen M, Kehmeier E, Veulemans V, Kelm M, Willems S, Meyer C. Left Atrial Appendage Closure Guided by Integrated Echocardiography and Fluoroscopy Imaging Reduces Radiation Exposure. PLoS One. 2015 Oct 14;10(10):e0140386. doi: 10.1371/journal.pone.0140386. eCollection 2015. PubMed 26465747 ↗
  • Drexel T, Eickholt C, Muhlsteff J, Ritz A, Siekiera M, Kirmanoglou K, Schulze V, Shin DI, Balzer J, Rassaf T, Kelm M, Meyer C. Vagal heart rate control in patients with atrial fibrillation: impact of tonic activation of peripheral chemosensory function in heart failure. Adv Exp Med Biol. 2013;755:287-97. doi: 10.1007/978-94-007-4546-9_37. PubMed 22826079 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01262508
Lead sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible party
Klinik für Kardiologie, Pneumologie und Angiologie (Klinik für Kardiologie, Pneumologie und Angiologie Christian Meyer, MD, Heinrich-Heine University, Duesseldorf) — Sponsor-investigator
First posted
Dec 17, 2010
Start date
Sep 2010
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Feb 19, 2016

Study contacts

Christian Meyer, MD
study chair · University of Duesseldorf
Malte Kelm, MD, PhD
study director · University of Duesseldorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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